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The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures (ARCTIC CAT)

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ClinicalTrials.gov Identifier: NCT01104831
Recruitment Status : Terminated (Inadequate recruitment.)
First Posted : April 16, 2010
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Orthopedic Research and Education Foundation
Orthopedic Trauma Association
Information provided by:
University of Manitoba

Brief Summary:

Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.

Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement


Condition or disease Intervention/treatment Phase
Proximal Tibia Fracture Device: Cryotherapy Device: Room temperature cuff Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
Study Start Date : April 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 21 degree Cooling
Room temperature water circulated through cryotherapy sleeve.
Device: Room temperature cuff
sleeve with room temperature water placed over fracture site.
Active Comparator: 10 degree cooling
Cooled water circulated through a cryotherapy sleeve.
Device: Cryotherapy
cooled sleeve placed over fracture site.



Primary Outcome Measures :
  1. Cost [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. VAS Pain Score [ Time Frame: 2 weeks ]
  2. Narcotic Requirements [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature
  • Trauma patients with single-system musculoskeletal injuries.
  • Proximal tibia fractures treated with open reduction and internal fixation.
  • Unilateral proximal tibial injuries.

Exclusion Criteria:

  • Previous ipsilateral knee surgery
  • Upper extremity injuries impairing mobilization
  • Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
  • Associated injuries impairing mobilization
  • Suspected or confirmed compartment syndrome
  • Open fractures
  • Patients previously on narcotics
  • Patients with impaired sensorium Concurrent head injury Intoxication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104831


Locations
Canada, Manitoba
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Orthopedic Research and Education Foundation
Orthopedic Trauma Association
Investigators
Principal Investigator: Jesse A Shantz, MD, MBA University of Manitoba

Responsible Party: Jesse Shantz, University of Manitoba
ClinicalTrials.gov Identifier: NCT01104831     History of Changes
Other Study ID Numbers: B2009:035
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: April 2011

Keywords provided by University of Manitoba:
Tibial Plateau Fracture
AO/OTA 41

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries